Apparatus and method for sealing a vascular puncture

ABSTRACT

A closure system for delivering a sealant to an arteriotomy. A distal section of the closure system can include overlapping inner and outer sleeves that can expand with expansion of the sealant. A proximal section of the closure system can include a handle portion and a sheath adapter extending from the handle portion. The handle portion can comprise one or more actuators that when depressed or engaged can assist in deployment of the sealant in the arteriotomy and can further include tamping of the sealant and/or retraction of an expandable member. The sheath adapter can removably engage a side port or an irrigation line of a standard procedural sheath. When the sheath adapter is secured to the procedural sheath, movement of the closure system can also move the procedural sheath.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is a continuation of U.S. patent applicationSer. No. 14/941,222 filed Nov. 13, 2015, which claims priority to U.S.Provisional Patent Application No. 62/079,878 filed Nov. 14, 2014. Theentire disclosure contents of these applications are herewithincorporated by reference into the present application.

FIELD

Percutaneous apparatuses and methods for sealing a vascular punctureusing a plug or sealant.

BACKGROUND

To obtain percutaneous access to a patient's vasculature, a hollowneedle may be inserted through a patient's skin and into a blood vessel.A guide wire may be passed through the needle lumen into the bloodvessel, whereupon the needle may be removed. An introducer sheath maythen be advanced over the guide wire into the vessel in conjunction withor subsequent to one or more dilators. A catheter or other device may beadvanced through the introducer sheath and over the guide wire into aposition for performing a medical procedure. Upon completing theprocedure, the device(s) and introducer sheath may be removed, leaving apuncture extending between the skin and the vessel wall. To seal thepuncture, external pressure may be applied to the overlying tissue,e.g., manually and/or using sandbags, until hemostasis occurs.

After completion of a diagnostic or therapeutic procedure requiringaccess to the vasculature (e.g., imaging procedure, angioplasty, stentdelivery, or otherwise), the arteriotomy can be closed by variousmechanical or biological solutions, such as by applying externalpressure, cinching, suturing, and/or delivering metal implants, plugs,or sealants. However, many of these closure procedures may be timeconsuming, expensive, and uncomfortable for the patient, requiring thepatient to remain immobilized in the operating room, catheter lab, orholding area for long periods of time. Additionally, some of theseprolonged closure procedures may increase the risk of hematoma frombleeding prior to hemostasis.

Some closure procedures may require a sheath exchange between theintroducer sheath used during the diagnostic or therapeutic procedureand a sheath that is compatible with the closure system. This additionalstep may be time consuming and increases the risk of vessel injury andinfection. Accordingly, there is still a need for a closure method thateliminates the sheath exchange step. The present disclosure is directedtoward a closure system that is compatible with a standard proceduralsheath and integrates the standard procedural sheath into a sealantdelivery method.

SUMMARY

Certain aspects of the disclosure are directed toward methods andclosure systems for sealing an arteriotomy. The closure system can beintroduced through a standard procedural sheath and can include a sheathadapter configured to engage the procedural sheath, particularly a sideport or an irrigation line of the procedural sheath.

Introducing the closure system through the existing procedural sheatheliminates the need for a custom sheath as well as eliminating the stepsassociated with a sheath exchange, including insertion of a guidewire,removing the existing sheath and inserting the custom sheath.Elimination of sheath exchange reduces risk of arterial trauma andvessel damage, maintains arterial access, saves time, limits leakage andbleeding and minimizes the possibility of hematoma or infection. Inorder to eliminate the need for a custom sheath, an integrated sheathcan be provided within the closure system and can be comprised of twosleeves, an inner and an outer sleeve.

In certain aspects, the method can include advancing a closure systemthrough a procedural sheath extending through the arteriotomy. Themethod can also include securing the sheath adapter of the closuresystem to the procedural sheath by releasably attaching the attachmentstructure of the sheath adapter to a side port or an irrigation line ofthe procedural sheath, and retracting the handle portion to retract theprocedural sheath and the outer catheter relative to the inner catheterto expose the sealant. The method can further include tamping thesealant with the support tube member.

In certain aspects, the closure system can include a handle portion, anda sheath adapter extending from the handle portion. The sheath adaptercan include an attachment structure for releasable attachment to aprocedural sheath.

In certain aspects, the closure system can include an outer catheterextending from a handle portion. The outer catheter can include aproximal section and a distal section. The distal section can include aninner sleeve and an outer sleeve surrounding the inner sleeve. The innersleeve can include a first slit, and the outer sleeve can include asecond slit circumferentially displaced from the first slit. The slit inthe outer sleeve or primary sleeve can be provided to mitigate jammingof the sleeve/sealant and to ease friction as the sleeve is retractedduring sealant delivery. The inner sleeve or secondary sleeve can beprovided to help contain the sealant when the tip of the catheter isintroduced into the vessel.

Optionally, any of the closure systems described above can include aninner catheter extending through an outer catheter, a support tuberadially between the outer catheter and the inner catheter, and/or asealant positioned in a distal section of the outer catheter.

In certain aspects, the closure system can include a first actuatorconfigured to unlock the inner catheter with respect to the handle. Thehandle can include a second actuator configured to advance a supporttube or member through the procedural sheath to help tamp the deployedsealant. For example, the handle can include a cam drive mechanism, thecam can be linked to the second actuator and configured to cause thesupport member to move. In certain aspects, the handle can furtherinclude a third actuator configured to retract the expandable structurethrough the sealant. The third actuator can be a retraction slider thatmoves relative to the inner housing portion.

In an alternative embodiment, the closure system can comprise a firstactuator that is configured to both retract the outer sleeve, thus atleast partially exposing the sealant, and to tamp the sealant againstthe arteriotomy. A second actuator can be provided to retract theexpandable structure.

A closure system that comprises a handle that has at least one actuatoror other type of controller mechanism that can reveal the sealant, tampthe sealant and/or retract the expandable structure is provided herein.In another embodiment, a closure system that comprises a handle havingat least two actuators or any other type of controller mechanism thatcan reveal the sealant, tamp the sealant and retract the expandablestructure, alone or in any combination thereof. In yet anotherembodiment, a closure system is provided that comprises a handle havingat least three actuators or any other type of controller mechanism thatcan reveal the sealant, then tamp the sealant and finally retract theexpandable structure.

Any feature, structure, or step disclosed herein can be replaced with orcombined with any other feature, structure, or step disclosed herein, oromitted. Further, for purposes of summarizing the disclosure, certainaspects, advantages, and features of the devices have been describedherein. It is to be understood that not necessarily any or all suchadvantages are achieved in accordance with any particular embodimentsdisclosed herein. No individual aspects of this disclosure are essentialor indispensable.

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-1I illustrate a method of using an embodiment of a closuresystem for delivering a sealant to an arteriotomy site.

FIG. 2 illustrates an enlarged view of a distal portion of the closuresystem shown in FIG. 1B taken through line 2-2.

FIG. 3 illustrates an enlarged view of a sheath adapter of the closuresystem shown in FIG. 1C taken through line 3-3.

FIG. 4 illustrates another embodiment of a sheath adapter that can beused with the closure system shown in FIGS. 1A-1I.

FIG. 5 illustrates another embodiment of a sheath adapter that can beused with the closure system shown in FIGS. 1A-1I.

FIG. 6 illustrates another embodiment of a sheath adapter that can beused with the closure system shown in FIGS. 1A-1I.

FIG. 7 illustrates another embodiment of a sheath adapter that can beused with the closure system shown in FIGS. 1A-1I.

FIG. 8 illustrates another embodiment of a sheath adapter that can beused with the closure system shown in FIGS. 1A-1I.

FIGS. 9A-9G illustrate a method of using a second embodiment of aclosure system for delivering a sealant to an arteriotomy site.

FIGS. 10A-10B illustrate an interior section close-up of a firstactuator of the handle device shown in FIGS. 9A-9G.

FIG. 10C illustrates a close-up view of a distal end of the handledevice shown in FIGS. 9A-9G.

FIGS. 11A-C illustrate one aspect of a visual indication system on thehandle shown in FIGS. 9A-9G.

FIGS. 12A-12B illustrate an interior section close-up of a secondactuator of the handle device shown in FIGS. 9A-9G.

FIGS. 13A-13D illustrate an interior section close-up of a thirdactuator of the handle device shown in FIGS. 9A-9G.

FIG. 14A illustrates a third embodiment of a closure system fordelivering a sealant to an arteriotomy site.

FIG. 14B illustrates an interior section view of the closure system ofFIG. 14A.

FIG. 14C illustrates a close-up view of a distal end of the handledevice of FIG. 14A, further depicting a tension indicator.

FIGS. 15A-15D illustrate interior section views of the first actuator ofthe closure system in FIG. 14A.

Various embodiments are depicted in the accompanying drawings forillustrative purposes, and should in no way be interpreted as limitingthe scope of the embodiments. Furthermore, various features of differentdisclosed embodiments can be combined to form additional embodiments,which are part of this disclosure.

DETAILED DESCRIPTION

A closure system for delivering a sealant to an arteriotomy and a methodof use for sealing same is provided herein. The closure system furtherincludes a sheath adaptor for attachment to an existing proceduralsheath and, thus, avoiding the need for a sheath exchange by removingthe procedural sheath and inserting another sheath. FIGS. 1A-1Iillustrate a method of delivering a sealant 18 to an arteriotomy site 2using a closure system 20. In general, the closure system 20 can includea handle portion 30 having a first actuator 32, a second actuator 34,and a third actuator 36 that can be used to control the features of theclosure system 20. An outer catheter 22 can extend from the handleportion 30 and can move axially with the handle portion 30. The handleportion 30 can include a sheath catch 40, or sheath adaptor, at a distalsection of the handle portion 30.

An inner catheter 24 can extend through the outer catheter 22. The innercatheter 24 can include an expandable structure 26 positioned at adistal section of the inner catheter 24. The inner catheter 24 can moveaxially relative to the outer catheter 22, for example, by actuating thefirst actuator 32 to release the inner catheter 24 from the outercatheter 22 and by retracting or advancing the third actuator 36 to movethe inner catheter 24. Although the examples provided herein willdescribe the expandable structure 26 as a balloon, the expandablestructure could alternatively be a basket, expandable wire braid,expandable mesh, expandable frame, rotatable structure, and the like. Inan alternative embodiment, the expandable structure may include abioabsorbable foot plate or other element on one end, e.g., forproviding tactile feedback to the user during a sealing procedure and/orsealing the puncture.

The sealant 18 can be positioned in a distal section 60 of the outercatheter 22, radially between the inner catheter 24 and the outercatheter 22. For example, the inner catheter 24 can extend through thesealant 18, while the outer catheter 22 surrounds the sealant 18. Thesealant 18 may include a first, proximal or main section formed fromfreeze-dried hydrogel, and a second, distal, or tip section (not shown)formed from a plurality of non-freeze-dried and/or non-cross-linkedprecursors, e.g., formed as a solid mass or solid plug, fused orotherwise attached to and extending distally from the first section, asdisclosed in U.S. application Ser. No. 13/354,278, titled “Apparatus andMethods for Sealing a Vascular Puncture,” filed Jan. 19, 2012, andincorporated herein by reference in its entirety. Additional detailsregarding sealant composition can be found in U.S. Pat. No. 7,335,330,titled “Apparatus and methods for sealing a vascular puncture,” filedNov. 5, 2004, and incorporated herein by reference in its entirety.

A support tube 28 or support member can be positioned proximal to thesealant 18, radially between the inner catheter 24 and the outercatheter 22. For example, the support member 28 can be tubular such thatthe inner catheter 24 can extend through the support member 28, whilethe outer catheter 22 surrounds the support member 28. Thus, the supportmember 28 can include a lumen extending between a proximal end anddistal end to accommodate slidably receiving the inner catheter 24therethrough. The support member 28 can support the sealant 18 duringthe positioning of the sealant 18 and tamp the sealant 18 against thevessel wall V to close the arteriotomy 2. The support member 28 may besubstantially rigid, semi-rigid, and/or substantially flexible, e.g.,having sufficient column strength to allow proximal movement of theclosure system relative to the sealant 18 without buckling the supportmember 28 and/or to allow the distal end of the support member 28 to beadvanced to compress the sealant 18 within a puncture. The supportmember 28 can move axially relative to the outer catheter 22 and theexpandable structure on the inner catheter 24, for example, by actuatingthe second actuator 34. In some configurations, actuating the secondactuator 34 can release the inner catheter 24 from the support member28.

In combination with or in place of any of the features described herein,the closure system 20 can include any of the features of the sealantdelivery apparatuses described in U.S. Publication No. 2014/0025103,filed Sep. 25, 2013, which is hereby incorporated by reference in itsentirety.

FIG. 1A illustrates a procedural sheath 10 extending through anarteriotomy 2. The procedural sheath 10 can be the same sheath usedduring the diagnostic and/or therapeutic procedure. As shown in FIG. 1A,the procedural sheath 10 can include a hub portion 14 having a side port16. The side port 16 can be secured to an irrigation and/or aspirationline 12.

After the diagnostic and/or therapeutic procedure, the closure system 20can be introduced through the procedural sheath 10 by introducing theouter catheter 22 through the hub portion 14 (see FIG. 1B). The outercatheter 22 can be sized to be compatible with 5F or larger standardprocedural sheaths.

The closure system 20 can be advanced through the procedural sheath 10until the sheath adaptor 40 engages the hub portion 14 of the proceduralsheath 10 (see FIG. 1C). As described in further detail below, thesheath adaptor 40 can be designed to removably engage the side port 16or irrigation line 12 of the hub portion 14.

With the closure system 20 coupled to the procedural sheath 10, theexpandable structure 26 of the inner catheter 24 can be expanded usingthe syringe 50 (see FIG. 1D). The expandable structure 26 can beexpanded until the inflation indicator 54 indicates the expandablestructure 26 has been expanded to a pre-determined pressure. Forexample, the inflation indicator 54 can move from a first position to asecond position when the expandable structure 26 is fully expanded. Asshown in FIG. 1D, the inflation indicator 54 in the second position canprotrude from a proximal end of the handle portion 30; however, theinflation indicator 54 can be positioned elsewhere on the handle portion30. Alternatively, any other appropriate inflation indicator can beemployed. One alternative can include a pressure gauge with a dial thathas a needle indicator that displays pressure readings and can show thecomplete inflation of the balloon. After the expandable structure 26 hasbeen expanded, the inflation line 56 can be sealed by closing the valve52.

With the expandable structure 26 expanded, the closure system 20 and theprocedural sheath 10 can be retracted until the expandable structure 26abuts an inner surface of the vessel wall V (see FIG. 1E).

The inner catheter 24 can be released from the outer catheter 22 byactuating or depressing the first actuator 32. After the inner catheter24 has been released, the procedural sheath 10 and the outer catheter 22can be retracted relative to the inner catheter 24 to expose the sealant18 (see FIG. 1F). In this configuration, the handle portion 30 can slideover the first actuator 32 to retract the outer catheter 22, while theinner catheter 24 remains in place.

With the sealant 18 exposed, the support member 28 can be advanced totamp the sealant 18 against an outer surface of the vessel wall V. Asdescribed above, actuation or depression of the second actuator 34 canadvance the support member 28 relative to the inner catheter 24 and theouter catheter 22.

After the sealant 18 has been tamped, the expandable structure 26 can becontracted, for example, by opening the valve 52 and deflating theexpandable structure 26 using the syringe 50 (see FIG. 1H). With theexpandable structure 26 contracted, the expandable structure 26 can beretracted through the sealant 18 by actuating or depressing the thirdactuator 36. The inner catheter 24 can be retracted relative to theouter catheter 22 and/or support member 28 (see FIG. 1I). After theexpandable structure 26 has been retracted through the sealant 18, theentire closure system 20 and procedural sheath 10 can be removed fromthe body, leaving the sealant 18 in place against the vessel wall V.Since the sheath adapter 40 is coupled to the procedural sheath 10, theclosure system 20 and the procedural sheath 10 can be removed together,but the closure system 20 could be disengaged from the procedural sheath10 and removed separately.

FIG. 2 illustrates an enlarged view of the closure system 20 prior tosealant delivery. As described above, the sealant 18 can be positionedin a distal section 60 of the outer catheter 22, radially between theinner catheter 24 and the outer catheter 22. The support member 28 canbe positioned proximal to the sealant 18. At least the distal section 60of the outer catheter 22 can include an outer sleeve 62 and an innersleeve 64. Each of the outer sleeve 62 and the inner sleeve 64 caninclude at least one slit 62 a, 64 a, respectively (e.g., one slit, twoslits, three slits, or more). The outer sleeve 62 and the inner sleeve64 can include the same number of slits or different numbers of slits.The slits 62 a, 64 a can be positioned so that the slits are not alignedwith each other. In one aspect, the outer slit 62 a can be positionedopposite the inner slit 64 a (e.g., about 180 degrees apart). The innerand outer sleeves 62, 64 can be overlapping such that the sealant 18 iscircumferentially surrounded by the combination of the inner and outersleeves 62, 64 to minimize exposure to bodily fluids entering the outercatheter 22 through the slits 62 a, 64 a.

In one aspect, the outer sleeve 62 can be longer than the inner sleeve64. The outer sleeve 62 can extend back to the handle portion 30, forexample such that it is integral with the outer catheter, while theinner sleeve 64 can be secured to the outer sleeve 62 proximal to theslits 62 a, 64 a. The inner sleeve 64 and the outer sleeve 62 can beattached using a thermal attachment, adhesive bond, mechanical bond, orother appropriate attachment method. With the inner sleeve 64 disposedwithin the outer sleeve 62, an inner diameter of the distal section 60can be less than an inner diameter of a proximal section of the outercatheter 22.

In one instance, the inner sleeve 64 can be stiffer than the outersleeve 62 to provide support for the outer sleeve 62. For example, theinner sleeve 64 and the outer sleeve 62 can have varying thicknessesand/or be constructed from different materials. In one embodiment, theinner sleeve 64 can be constructed from polyimide or a similarly rigidpolymer, while the outer sleeve 62 can be constructed from a softermaterial, such as polyamide. In another embodiment, the outer sleeve 62can be constructed from a polyether block amide, such as Pebax®, or froma nylon material. However, any other appropriate materials may be usedfor the inner and outer sleeves. Although not shown, in another aspect,the outer sleeve 62 can be thermally shaped with a smaller radius at thedistal end to provide an atraumatic tip during delivery.

The dual layer sleeve 62, 64 can help maintain the sealant in theclosure system 20 when the closure system 20 is being retracted throughthe arteriotomy. The slit design of the distal section 60 reducesfriction during deployment of the sealant and reduces the risk ofjamming the sealant. For example, if the sealant 18 begins to expandwhile still positioned in the closure system 20 (e.g., from bodilyfluids entering from a distal end), the slit design of the distalsection 60 provides space for the sealant 18 to expand without jammingthe closure system 20.

FIGS. 9A-9G illustrate a second embodiment of a closure system 120. Inthis embodiment, the closure system 120 can comprise one or moreactuators that assist in deploying the sealant, tamping the sealant andretracting the expandable structure and, in particular, three actuators.Similar features to the first embodiment illustrated and discussed inFIGS. 1A-1I have similar numbers.

Similar to the function of the closure system 20 in FIG. 1B, the closuresystem 120 can be introduced through the procedural sheath 10 byintroducing the outer catheter 22 through the hub portion 14 (see FIG.9A). The outer catheter 22 can be sized to be compatible with 5F orlarger standard procedural sheaths.

The closure system 120 can be advanced through the procedural sheath 10until the sheath adaptor 40 engages the hub portion 14 of the proceduralsheath 10. As described in further detail below, the sheath adaptor 40can be designed to removably engage the side port 16 or irrigation line12 of the hub portion 14.

Similar to the first embodiment presented above, the inner catheter 24can extend through the outer catheter 22. The inner catheter 24 caninclude an expandable structure 26, such as a balloon or otherappropriate element as discussed above, positioned at a distal sectionof the inner catheter 24. The inner catheter 24 can move axiallyrelative to the outer catheter 22, for example, by actuating ordepressing the first actuator 32 to release the inner catheter 24 fromthe outer catheter 22 and by actuating or depressing the third actuator36 to move the inner catheter 24 into the support member 28. In order toprovide compatibility with the existing procedural sheath, the sheath ofthe closure system is integrated with the device handle. This can beaccomplished by providing the inner sleeve 64 and the outer sleeve 62which form the inner/outer sleeve assembly, e.g., the two sleeves at thedistal end. This integrated sheath, e.g., outer catheter 22, can befixed to the handle and retracts during sealant deployment. The outercatheter 22 can move radially within the handle to minimize the impactof torsional forces on the outer catheter 22 and on the outer sleeve 62;this can allow the outer sleeve 62/catheter 22 to rotate freely withinthe handle.

With the closure system 120 coupled to the procedural sheath 10, theexpandable structure 26 of the inner catheter 24 can be expanded usingthe syringe 50 (see FIG. 9B). The expandable structure 26 can beexpanded until the inflation indicator 154 indicates the expandablestructure 26 has been expanded to a pre-determined pressure. Forexample, the inflation indicator 154 can move from a first position to asecond position when the expandable structure 26 is fully expanded. Asshown in FIG. 9B, the inflation indicator 154 in the second position canprotrude from a proximal end of the handle portion 130; however, theinflation indicator 154 can be positioned elsewhere on the handleportion 130. After the expandable structure 26 has been expanded, theinflation line 56 can be sealed by closing the valve 52. With theexpandable structure 26 expanded, the closure system 120 and theprocedural sheath 10 can be retracted until the expandable structure 26abuts an inner surface of the vessel wall V.

The inner catheter 24 can be released from the outer catheter 22 byactuating or depressing the first actuator 132. As the inner catheter 24is released, the procedural sheath 10 and the outer catheter 22 can alsobe retracted relative to the inner catheter 24 to expose the sealant 18by simultaneously retracting the handle and the procedural sheath (seeFIG. 9C). In this configuration, the handle portion 130 slides over thefirst actuator 132 to retract the outer catheter 22, while the innercatheter 24 remains in place. As the first actuator 132 is depressed andthe handle body 130 is slid back, a visual indication 180 becomesvisible through a window 182 that is exposed upon sliding the handle 130proximally covering the first actuator 132 to display an imageindicating whether the sealant has been properly deployed.

With the sealant 18 exposed, the support member 28 can be advanced totamp the sealant 18 against an outer surface of the vessel wall V.Actuation or depression of the second actuator 134 can advance thesupport member 28 relative to the inner catheter 24 and the outercatheter 22. Additionally, the visual indicator 180 visible through thewindow 182 can display a different image that indicates the tamping ofthe sealant has been completed successfully and initiation of dwellperiod of sealant activation.

After the second actuator 134 has been depressed, but before the thirdactuator 136 has been depressed, the inflation indicator 154 can providea lockout feature that prevents the third actuator 136 from beingdepressed while the expandable structure 26 is in an expandedconfiguration (see FIG. 9E). The inflation indicator 154 can extendthrough a proximal portion of the handle 130 such that a distal portionof the inflation indicator 154 is positioned below the third actuator136. When the inflation indicator 154 is in the second position (e.g.,extending beyond the proximal end of the handle 130) this not onlyindicates that the expandable structure 26 is inflated but furtherprovides a blocking segment 140 integral with the inflation indicator154 but internal to the handle body.

After the sealant 18 has been tamped, the expandable structure 26 can becontracted, for example, by opening the valve 52 and deflating theexpandable structure 26 using the syringe 50 (see FIG. 9F). With theexpandable structure 26 contracted, the expandable structure 26 can beretracted through the sealant 18 by actuating the third actuator 136.The inner catheter 24 can be retracted relative to the outer catheter 22and/or support member 28 (see FIG. 9G). After the expandable structure26 has been retracted through the sealant 18, the entire closure system20 and procedural sheath 10 can be removed from the body, leaving thesealant 18 in place against the vessel wall V. Since the sheath adapter40 is coupled to the procedural sheath 10, the closure system 20 and theprocedural sheath 10 can be removed together, but the closure system 20could be disengaged from the procedural sheath 10 and removedseparately.

Turning now to FIGS. 10A-13B, the handle portion 130 of the closuresystem 120 is illustrated in further detail. The interior of the handle130 contains a proximal 142 and distal 144 sled assembly that slides orglides within the interior of the handle as it is actuated, as shown inFIGS. 10A-10B. The distal sled assembly 144 can integrate the firstactuator 132, such that when the first actuator is depressed and thehandle is retracted, the distal sled assembly moves distally withrespect to the handle, as shown in FIG. 10B. The proximal 142 and distal144 sled assemblies are in a locked position with respect to the handle130 until the first actuator 132 is fully depressed and locked into asecond, depressed position. Upon depression of the first actuator 132,both distal sled assembly 144 and the proximal sled assembly 142 areunlocked and can move distally with respect to the handle body 130 whenthe handle is retracted. The proximal sled assembly 142 can house theinner catheter 24 and the inflation indicator.

Turning to FIG. 10C, a close-up view of the device 120 is shown attachedand locked with the procedural sheath at catch 40. The sheath catch oradaptor 40 can be oriented in any position or direction and,alternatively, can be provided such that it may be able to rotate aboutthe handle 130 such that it can be adjusted to more easily catch theport or irrigation line of the procedural sheath.

In addition to actuating the distal sled assembly, the first actuator132 can also display a visual indication 180 through a window 182 thatcan provide a storyboard for the user to understand that the outersleeve has been successfully retracted and the sealant deployed, asshown in FIGS. 11A-C. FIG. 11A shows a portion of the handle body 130containing the first actuator, where the first actuator 130 can alsooptionally have a visual indication to identify that it is the firstactuator in a series of actuators. Upon actuating or depressing thefirst actuator 132, a first image or visual indication can becomevisible and, for example, can display a symbol such as a check mark orother appropriate symbol through the window 182 to indicate that thesealant has been deployed, as shown in FIG. 11B. Once the secondactuator 134 is also depressed, the storyboard can further displayanother image to convey that the sealant has been successfully tamped,as shown in FIG. 11C. Although a check mark and a circle with a symbolin it are shown, any visual indication or image may be used asappropriate to indicate the step completed.

The second actuator 134 can include a cam drive mechanism, as shown inFIGS. 12A-12B, that can drive the distal sled assembly 144 associatedwith the first actuator 132 and support member 28 in a distal directionto tamp the sealant. The second actuator 134 can interface with a ramp146 on the proximal end of the distal sled assembly 144/first actuator132, which can be overmolded onto the support member 28 such that anydistal movement of the distal sled assembly 144 can also move thesupport member 28 in a distal direction. When the second actuator 134 isdepressed, the distal face 148 of the second actuator 134 can contactthe ramp 146 of the distal sled assembly 144 pushing it in a distaldirection and can advance the distal sled assembly 144 and the supportmember 28 in a distal direction causing the sealant to be compressed andtamped by advancement of the support member 28.

The third actuator 136 can be depressed to retract the deflatedexpandable structure 26 back into the support member 28, as seen inFIGS. 13A and 13B. In one aspect, the retraction of the expandablestructure 26 can be accomplished by an arm 150, as seen in a furtherclose-up interior view in FIGS. 13C and 13D, that extends from the thirdactuator 136 and below a top/outer surface of the third actuator 136. Asthe third actuator 136 is depressed, it can cause the arm 150 to engagewith the inner catheter 24 and upon engaging the catheter, the arm cankink the inner catheter 24 on the proximal end, such that it can bendthe catheter 24 away from a central axis of the handle 130, as seen inFIG. 13D, causing it to retract in the proximal direction, therebycausing the expandable structure 26 to retract into the support member28.

In addition, if the expandable structure 26 is in an inflated state, asindicated by the inflation indicator 154 being extended beyond theproximal end of the handle 130, then the third actuator 136 cannot bedepressed due to a lock-out feature. The lock-out feature is provided bya portion of the inflation indicator 154 that extends internally anddistally into the handle 130 and further having protrusions 140 thatextend axially outward away from the central axis of the handle 130which act as a lock or stop that prevents the third actuator 136 frombeing depressed. When the expandable structure 26 is deflated, then theinflation indicator 154 can be shifted in a distal direction, such thatit is no longer visible proximal to the handle. This motion of theinflation indicator 154 can also shift the position of the protrusions140 that lock the third actuator 136 in place. Once shifted, the thirdactuator 136 is free to be depressed. This lockout feature provided bythe inflation indicator 154 is beneficial in preventing an accidentaldepression of the third actuator 136 such that the expandable structureis not retracted prior to being fully deflated. In an alternativeaspect, the lockout element can be a protrusion that extends axiallytoward the center of the handle 130 and locks out the distal arm on thethird actuator 136 such that the third actuator 136 cannot be depressed.

An alternate embodiment of a closure system 220 is illustrated in FIGS.14A-15D. In this embodiment, the closure system 220 can comprise twoactuators that assist in deploying the sealant, tamping and retractingthe expandable structure. Similar features to the first and secondembodiments have similar reference numerals.

Similar to the function of the closure system 20 in FIG. 1B, the closuresystem 220 can be introduced through a procedural sheath (not shown) byintroducing the outer catheter 22 through the hub portion 14 (notshown). The outer catheter 22 can be sized to be compatible with 5F orlarger standard procedural sheaths.

As seen in FIG. 14A the handle 230 can contain at least one actuatorand, in particular, two actuators. Although not shown, the closuresystem 220 can also be advanced through the procedural sheath until thesheath adaptor 40 engages the hub portion of the procedural sheath, justas in the previous embodiments. The closure system 220 can perform in asimilar manner as the previous embodiments in regard to advancementthrough the procedural sheath and locking the handle via the sheathadaptor 40 to the procedural sheath.

Turning to FIG. 14A, the handle 230 is shown having a first actuator 222and a second actuator 224. The first actuator 222 can have a combinedfunction that both retracts the outer catheter 22 and tamps the sealant18 when actuated. The second actuator 224 can have a function that issimilar to the third actuators 36 and 136 from the previous embodiments.When the second actuator 224 is depressed, it can retract the expandablestructure 26 into the support member or tube 28. Although FIGS. 14A-15Donly show the closure device, the device can be employed in a similarmanner as depicted in FIGS. 1B-1I and 9A-9G to effect a closure processin an arteriotomy.

Additionally, a tension indicator 206 can be incorporated into thehandle 230 design, as shown in FIG. 14C, by including a tensionindicator window 228 through which an illustration or image can bevisible that indicates whether proper tension has been applied on theexpandable structure 26 upon placement of the expandable structure 26 atthe inner surface of the vessel wall, V. The tension indicator 206 canprovide a visual cue to the user when the proper amount of tension hasbeen applied to the expandable structure 26 prior to deploying thesealant 18. It is beneficial to know when the tension is appropriatebecause if excessive tension is exerted by the expandable structure 26on the arterial wall it can cause the vessel to tent (e.g., distend)such that the artery is moved out of its initial position, e.g., itsoriginal anatomical position, during the closure process. If the sealant18 is deployed with the artery in this tented position, then the tissuecompression around the tented vessel may elicit a subtle separation ofthe hydrogel sealant 18 from the surface of the puncture site as theartery returns to its normal position after the expandable structure 26is deflated and the device 220 is removed from the patient.

Turning to FIG. 14B, an internal view of the handle 230 is illustrated.The handle 230 can have a proximal sled assembly 242 that can house theinner catheter 24, similar to the other embodiments. When the expandablestructure 26 is inflated in the patient's artery and pulled back to thearteriotomy, the expandable structure 26 can meet resistance when it isup against the vessel wall and the force exerted on the expandablestructure 26 can be transferred back to the proximal sled assembly 242.The proximal sled assembly 242 can move in a distal direction when theexpandable structure 26 is under tension, thereby compressing a tensionspring 202 housed in the tension indicator 206. The tension indicator206 can begin to move in a distal direction when the force on theexpandable structure 26 exceeds the pre-load on the tension spring 202.The first actuator 222 can be depressed when a protrusion or black lineon the tension indicator 206 lies within or is aligned with the propertension zone 226 on the device handle 230, illustrating that the tensionindicator 206 is in the appropriate position within the tensionindicator window 228, as illustrated in FIG. 14C.

If the tension indicator 206 does not line up with the proper tensionzone 226, then the first actuator 222 cannot be actuated or depressed,since the tension applied on the expandable structure 26 is not in theproper tension zone (e.g., black band). Thus, the tension indicator zone226 can include lockout features that can prevent the first actuator 222from being depressed when improper tension is applied via the expandablestructure 26. The tension zone 226 can be indicated in any manner and,in the embodiment shown in FIG. 14C, it is indicated by a black linemarked on the handle device 230. The position of the black line on thehandle 230 is positioned in the proper tension zone. The tensionindicator 206 can be a sliding piece inside of the handle assembly 230that can slide distally based upon the tension applied on the expandablestructure 26. Therefore, to ensure correct tension is being applied tothe expandable structure 26, the user can adjust the tension upon theexpandable structure 26 until the black line on the tension indicator206 is aligned with the black line on the handle of the tension zone226. The tension can be adjusted, in one aspect, by pulling back orletting up on the handle of the closure device, whichever is necessary.Alternatively, any other visual indication system may be used asappropriate to indicate proper tension applied to the expandablestructure 26.

Turning to FIGS. 15A-D, an internal view of the handle housing is shown,these views do not show the tension indicator 206, however, it can beincluded if desired as shown in FIGS. 14A-C. FIG. 15A illustrates thehandle 230 at rest, before the first actuator 222 has been depressed. Itcan be seen that in the rest position, an inner rib 212 on the firstactuator 222 can engage with or contact a ramp 214 on the pull rack 208.The pull rack 208 can be connected to the outer sleeve assembly 62 (notshown). As the first actuator 222 is actuated or depressed the pull rack208 can begin to shift in a proximal direction, e.g., away from thesheath adaptor 40. As the pull rack 208 shifts in a proximal directionby actuation of the first actuator 222, the outer sleeve 62 also beginsto shift in a proximal direction, thus, exposing the sealant in thetissue tract next to the arteriotomy. As the first actuator 222 is beinginitially depressed, as in FIG. 15B, the sealant can begin to be exposedby retraction of the sleeve.

As the first actuator 222 is depressed partially, as in FIG. 15B, thedistal face 218 of the first actuator 222 can engage with the push rack210 and can begin to shift the push rack 210 in a distal direction,e.g., toward the sheath adaptor 40, at a point that the sealant is atleast partially exposed and, in one aspect, is exposed about 50%. Thepush rack 210 can be connected to the support member 28, or tamp tube,such that when the push rack 210 is shifted in a distal direction it isalso shifting the support member 28 in a distal direction effectivelytamping the sealant against the vessel wall of the arteriotomy. Afterabout 50% of the sealant is exposed by the movement of the pull rack 208(e.g., as the first actuator is being initially depressed), both thepush rack 210 and pull rack 208 can move in their respective directionssimultaneously or relatively simultaneously revealing the sealant andtamping the sealant. It is preferable that at least a portion of thesealant be exposed prior to tamping; this can help to mitigate jammingof the sleeve and/or sealant. In this embodiment, about 50% of thesealant is exposed before the push rack 210 is engaged, however, anyother appropriate amount of the sealant can be exposed that is less thanor greater than 50% before engaging the push rack 210.

In FIG. 15C, the pull rack 214 is shown in its final position, shiftedproximal to where it began, while the push rack 216 is shown in itsfinal position, shifted distal to where it began. FIG. 15D shows thefirst actuator 222 fully depressed with the ramp 216 on the push rack210 exposed internal to the handle 230. The first actuator 222, orcombination actuator, can drive the pull rack 208 and the push rack 210utilizing a cam drive mechanism similar to the previous embodiment. Thefirst actuator 222 can include features that engage with each rack andcan drive them in the desired direction.

Although not illustrated, depressing the second actuator 224 can retractthe expandable structure 26 similar to how the third actuator functionsin the previous embodiments and can also further include a lockoutmechanism that can prevent the second actuator 224 from being depressedif the expandable structure 26 is still inflated, as indicated by theinflation indicator 254. This lockout feature is similar to thatdescribed above in regard to the second embodiment having a blockingsegment or protrusions 140 extending from the proximal sled assembly andas shown in FIGS. 10A, 10B, 13A and 13B.

This embodiment illustrates a handle device 230 having two actuators,however, the handle can have more or less actuators than that describedherein. For instance, the handle can be provided with only one actuatorthat carries out all of the functions described herein or one actuatorthat carries out one or more functions while another method is employedfor any remaining functions. Thus, the handle on the closure device canhave one or more actuators, as appropriate.

FIG. 3 illustrates an enlarged view of the sheath adapter 40 that canengage any sheath having a side port or irrigation line. The sheathadapter 40 can be integral with the handle portion 30 or a separatecomponent coupled to the handle portion 30, either directly or via anintervening catheter shaft or other linking structure.

As shown in FIG. 3, the sheath adapter 40 can have any shape that isappropriate and, in particular, can have a generally tubular,cylindrical or generally frustoconical shape. The sheath adaptor 40 caninclude polycarbonate, ABS, silicone, an elastomer, or other suitablematerials. An elastomeric material may be beneficial to enable thesheath adapter 40 to grip the side port 16 or irrigation line 12 of thesheath 10.

The sheath adapter 40 can include an attachment structure that canreleasably attach to a procedural sheath, such as a bayonet connector orhook portion 42 that can hook around a transverse retention surface suchas a distally facing surface on the side port 16 or irrigation line 12of a procedural sheath 10. The hook portion 42 can form a passageway 44that can guide the side port 16 or irrigation line 12 into engagementwith the sheath adapter 40. The hook portion 42 can be shaped such thatboth axial and rotational movement is required to disengage the hookportion 42 from the sheath 10.

The passageway 44 can be defined by a distal facing edge 48 a, an outerlateral edge 48 b, a proximal facing edge 48 c, an inner lateral edge 48d, and a hook end edge 48 e. The edges defining the passageway 44 can begenerally straight or curved. The distance D₁ between the distal facingedge 48 a and the hook end edge 48 e can be sized to permit the sideport 16 or irrigation line 12 to enter the passageway 44. For example,the distance D₁ can be within about 10% or within about 20% of adiameter of the side port 12 or the irrigation line 12, which can bebetween about 3F and about 11F, such as between about 3F and about 6F,between about 5F and about 8F, or between about 7F and 10F, includingabout 3F, 4F, 5F, 6F, 7F, 8F, 9F, 10F, or 11F.

The distance D₁ can be less than the distance D₂ between the distalfacing edge 48 a and the proximal facing edge 48 c (less than about 60percent of D₂, less than about 50 percent of D₂, less than about 40percent of D₂, less than about 30 percent of D₂, less than about 20percent of D₂, or otherwise).

The distance D₃ between the outer lateral edge 48 b and the innerlateral edge 48 d can be sized to receive the side port 16 or irrigationline 12 of the procedural sheath 10. For example, the distance D₃ can bewithin 10% of a diameter of the side port 16 or irrigation line 12,which can be between about 3F and about 11F, such as between about 3Fand about 6F, between about 5F and about 8F, or between about 7F and10F, including about 3F, 4F, 5F, 6F, 7F, 8F, 9F, 10F, or 11F. Thedistance D₃ can be less than the distance D₁.

The inner lateral edge 48 d can have a length suitable to block the sideport 16 or irrigation line 12 from disengaging from the sheath adapter40 when the closure system 20 is rotated. For example, the length of theinner lateral edge 48 d can be at least as long as a diameter of theside port 16 or the irrigation line 12. The length of the inner lateraledge 48 d can be at least about 20% of a length L of the sheath adapter40, at least about 30% of a length L of the sheath adapter 40, or atleast about 40% of a length L of the sheath adapter 40. The length ofthe inner lateral edge 48 d can be at least as long as the distance D₃.

Although not shown, in some embodiments, the distance D₃ can narrow fromthe proximal facing edge 48 c toward the hook end edge 48 e. The hookportion 46 can be spring-like and move away from the outer lateral edge48 b to enlarge the distance D₃ between the outer lateral edge 48 b andinner lateral edge 48 d to permit the side port 16 or irrigation line 12to move toward the proximal facing edge 48 c. The hook portion 46 canrebound back toward the outer lateral edge 48 b to retain the side port16 or irrigation line 12.

FIG. 4 illustrates an enlarged view of another sheath adapter 70 thatcan be used with the closure system 20 to engage any sheath having aside port or irrigation line. The sheath adapter 70 can be integral withthe handle portion 30 or a separate component coupled to the handleportion 30.

As shown in FIG. 4, the sheath adapter 70 can have a generallycylindrical or generally frustoconical shape. The sheath adaptor 70 caninclude polycarbonate, ABS, silicone, an elastomer, or other suitablematerials. An elastomeric material may be beneficial to enable thesheath adapter 40 to grip the side port 16 or irrigation line 12 of thesheath 10.

The sheath adapter 70 can include an attachment structure (e.g., abayonet connector) that can releasably attach to a procedural sheath.For example, the attachment structure can include a first hook portion72 having a first hook end portion 72 a and a second hook portion 74having a second hook end portion 74 a. At least a portion of the firstand second hook portions 72, 74 can extend distally beyond a distalfacing edge 76 of a remaining portion of the sheath adapter 70.

The first hook portion 72 and the second hook portion 74 can begenerally the same shape and size but inverted relative to each other,such that lower surfaces 72 b, 74 b of the first and second hookportions 72, 74 are tapered inward and toward each other to guide theside port 16 or irrigation line 12 toward a passageway 78. The sheathadapter 70 can be generally symmetrical across a plane extending betweenthe first and second hook portions 72, 74 and through the longitudinalaxis of the sheath adapter 70.

A distance B₁ between a first hook end portion 72 a and a second hookend portion 74 a can be less than a diameter of the side port 16 orirrigation line 12 to prevent the side port 16 or irrigation line 12from inadvertently detaching from the sheath adaptor 70. The hook ends72 a, 74 a can bend to enlarge the distance B₁ to allow the side port 16or irrigation line 12 to enter the passageway 78, but then rebound oncethe side port 16 or irrigation line 12 is in the passageway 78 such thatthe side port 16 or irrigation line 12 is retained between the hook ends72 a, 74 a and the distal facing edge 78 d. The spring-like hook ends 72a and 74 a can be designed to retain the side port 16 or irrigation line12 under normal use but can be overcome by the user if detachment of thesheath adapter 70 is necessary.

Each hook portion 72, 74 can define a portion of the passageway 78. Eachhook portion 72, 74 can have an inner lateral edge 78 a, a proximalfacing edge 78 b, an outer lateral edge 78 c, and a distal facing edge78 d. The edges defining the passageway 78 can be generally straight orcurved.

The distance B2 between the inner and outer lateral edges 78 a, 78 c canbe sized to permit the necessary bending of the hook portions 72, 74toward their respective outer lateral edge 78 c to allow the side port16 or irrigation line 12 to enter the passageway 78.

FIG. 5 illustrates an enlarged view of another sheath adapter 80 thatcan be used with the closure system 20 to engage any sheath having aside port or irrigation line. The sheath adapter 80 can be integral withthe handle portion 30 or a separate component coupled to the handleportion 30. As shown in FIG. 5, the sheath adapter 80 can include aproximal flange 82 to engage the handle portion 30.

As shown in FIG. 5, the sheath adapter 80 can have a generallycylindrical or generally frustoconical shape. The sheath adaptor 80 caninclude polycarbonate, ABS, silicone, an elastomer, or other suitablematerials. An elastomeric material may be beneficial to enable thesheath adapter 40 to grip the side port 16 or irrigation line 12 of thesheath 10.

The sheath adapter 80 can include an attachment structure that canreleasably attach to a procedural sheath, such as bayonet connector orhook portion 84. A distal facing edge 88 of the sheath adapter 80 canextend distally beyond the hook portion 84.

The hook portion 84 can form a passageway 86. The passageway 86 can bedefined by a hook end edge 86 a, a proximal facing edge 84 b, a firstinner lateral edge 86 c, a first distal facing edge 86 d, a second innerlateral edge 86 e, a second distal facing edge 86 f, and an outerlateral edge 86 g. The edges defining the passageway 86 can be generallystraight or curved.

The hook end edge 86 a can be tapered inward toward the passageway 86 toguide the side port 16 or irrigation line 12 toward the passageway 86. Adistance C₁ between the hook end edge 86 a and the outer lateral edge 86g can be sized to prevent the side port 16 or irrigation line 12 frominadvertently exiting the passageway 86. The hook portion 84 can be aspring-member that can be deflected away from the central axis of thesheath adapter 80 to enlarge C₁ to permit passage of the side port 16 orirrigation line 12 into the passageway 106. After the side port 16 orirrigation line 12 is positioned in the passage 86, the hook portion 84can return to its original state such that the side port 16 orirrigation line 12 is retained between the proximal facing edge 86 b andthe second distal facing edge 86 f.

The second distal facing edge 86 e can be proximal to the first distalfacing edge 86 c and spaced apart from the first distal facing edge 86 cby the second inner lateral edge 86 e. The second distal facing edge 86e can be generally curved to guide the side port 16 or irrigation line12 toward the inner lateral surface 86 c. The distance C₂ between thesecond inner lateral edge 86 e and the outer lateral edge 86 g can begreater than the distance C₁ and sized to receive the side port 16 orirrigation line 12. In one aspect, C₁ can be about 0.126 inches and C₂can be about 0.210 inches, however, other appropriate dimensions arepossible.

A length of the proximal facing edge 86 b and/or the first distal facingedge 86 d can be sufficient to enable the hook portion 84 to deflectoutward and enlarge the distance C₁ to permit passage of the side port16 or the irrigation line 12. For example, the proximal facing edge 86 band/or the first distal facing edge 86 d can extend around at least 20%of a circumference of the sheath adapter 80, at least about 30% of acircumference of the sheath adapter, at least about 40% of acircumference of the sheath adapter, or at least about 50% of acircumference of the sheath adapter 80. A length of the proximal facingedge 86 b can be longer than a length of the first distal facing edge 86d.

Alternatively, a distance C₃, between the proximal facing edge 86 b andthe first distal facing edge 86 d, can be sized to permit the side port16 or irrigation line 12 to traverse the passageway 86. The distance C₃can be within 10% or within about 20% of a diameter of the side port 16or irrigation line 12. The distance C₃ can be less than the distance C₁.

FIG. 6 illustrates an enlarged view of another sheath adapter 90 thatcan be used with the closure system 20 to engage any sheath having aside port or irrigation line. The sheath adapter 90 resembles the sheathadapter 80 discussed above in many respects. Accordingly, numerals usedto identify features of the sheath adapter 80 are incremented by afactor of one ten (10) to identify like features of the sheath adapter90.

Unlike the sheath adapter 80, the hook end edge 96 a of the sheathadapter 90 is generally straight and a distal section of the outerlateral edge 96 h can be tapered inward to guide the side port 16 orirrigation line 12 into the passageway 96. The distal section of theouter lateral edge 96 h and the proximal section of the outer lateraledge 96 g are separated by a proximal facing step 96 i.

The sheath adapter 90 can include a protruding portion or thumb grip 91extending radially outward from the sheath adapter 90, which allows forthe user to bend the hook end 96 a outward away from the central axis ofsheath adaptor 90 in order to enlarge C₁ and enable the removal of thesheath 10 from the sheath adaptor 90.

FIG. 7 illustrates an enlarged view of another sheath adapter 100 thatcan be used with the closure system 20 to engage any sheath having aside port or irrigation line. The sheath adapter 100 can be integralwith the handle portion 30 or a separate component coupled to the handleportion 30. As shown in FIG. 7, the sheath adapter 100 can include aproximal flange 102 to engage the handle portion 30. The proximal flange102 may have a detent feature that permits the user to rotate the sheathadapter 100 for optimal positioning to accommodate side ports positionedat various angles, but prevent rotation of the sheath adaptor 100 duringthe procedure.

As shown in FIG. 7, the sheath adapter 100 can include an attachmentstructure that can releasably attach to a procedural sheath, such as abayonet connector or hook portion 104. The hook portion 104 can protruderadially outward from the sheath adapter 100. The hook portion 104 canbe shaped such that axial and rotational movement are required todisengage the sheath adapter 100 from the sheath 10. Alternatively thehook portion 104 may be configured such that it must be depressed todisengage the sheath adapter 100 from the sheath 10.

The hook portion 104 can form a passageway 106. The passageway 106 canbe defined by a lower hook edge 106 a, a hook end edge 106 b, an upperhook edge 106 c, an inner lateral edge 106 d, a distal facing edge 106e, and an outer lateral edge 106 f. The edges defining the passageway106 can be generally straight or curved. The lower hook edge 106 a canbe generally tapered inward to guide the side port 16 or irrigation line12 toward the passageway 106.

A distance E₁ between the hook end edge 106 b and the outer lateral edge106 f can be sized to prevent the side port 16 or irrigation line 12from inadvertently escaping the passageway 106. The hook portion 104 canbe a spring-member that can be deflected toward the inner lateral edge106 d to decrease the distance E₃ and increase the distance E₁ to permitpassage of the side port 16 or irrigation line 12 into the passageway106. After the side port 16 or the irrigation line 12 is positioned inthe passageway 106, the hook portion 104 can return to its originalstate such that the side port 16 or irrigation line 12 is retainedbetween the distal facing edge 106 e and the hook end edge 106 b.

A length of the upper hook edge 106 c can be sufficient to enable thehook portion 84 to deflect toward the inner lateral edge 106 d andpermit passage of the side port 16 or irrigation line 12 into thepassageway 106. The length of the upper hook edge 106 c can besufficiently long to enable the hook end edge 106 to facilitate theretention of the side port 16 or irrigation line 12 and inhibit thesheath 10 from easily disengaging from the sheath adapter 100 when theclosure system is rotated or pulled. For example, a length of the upperhook edge 106 c can be at least about 20% of a length L of the sheathadapter 100, at least about 30% of a length L of the sheath adapter 100,or at least about 40% of a length L of the sheath adapter 100.

The distal facing edge 106 e can be generally curved to guide the sideport 16 or irrigation line 12 toward the portion of the passageway 106between the upper hook edge 106 c and the inner lateral edge 106 d. Thedistance E₂ between the inner lateral edge 106 d and the outer lateraledge 106 f can be greater than the distance E₁. In one aspect, E₁ can beabout 0.115 inches and E₂ can be about 0.210 inches, however, otherappropriate dimensions can be possible.

FIG. 8 illustrates another sheath adapter 110 that can engage any sheathhaving a side port 16 or irrigation line 12. The sheath adapter 110 canbe integral with the handle portion 30 or include a proximal flange 112to engage the handle portion 30.

As shown in FIG. 8, the sheath adapter 110 that can have a generallycylindrical or generally frustoconical shape. The sheath adaptor 110 caninclude polycarbonate, ABS, silicone, and elastomer or other suitablematerials. An elastomeric material may be beneficial to enable thesheath adapter 110 to grip the side port 16 or irrigation line 12 of thesheath 10.

The sheath adapter 110 can include an attachment structure that canreleasably attach to a procedural sheath, such as a bayonet connector orhook portion 114 that can hook around the side port 16 or irrigationline 12 of a procedural sheath 10. The hook portion 116 can extenddistally beyond a distal edge 118 of a remaining portion of the sheathadapter 110. The hook portion 114 can form a passageway 116 to retainthe side port 16 or irrigation line 12. The hook portion 114 can beshaped such that both axial and rotational movement is required todisengage the hook portion 114 from the sheath 10.

The passageway 116 can be defined by an outer lateral edge 116 a, aproximal facing edge 116 b, an inner lateral edge 116 c. The edgesdefining the passageway 116 can be generally straight or curved. Thedistance F₁ between the outer lateral edge 116 a and the an innerlateral edge 116 c can be sized to permit the side port 16 or irrigationline 12 to enter the passageway 116. For example, the distance F₁ can bewithin about 10% or within about 20% of a diameter of the side port 12or the irrigation line 12. In one aspect, F₁ can be about 0.200 inches,however, other appropriate dimensions are possible.

In some embodiments, the distance F₁ can narrow from the proximal facingedge 116 b toward the hook end edge 116 d. The hook portion 114 can bespring-like and move away from the inner lateral edge 116 c to enlargethe distance D₁ between the outer lateral edge 116 a and inner lateraledge 116 c to permit the side port 16 or irrigation line 12 to movetoward the proximal facing edge 116 b. The hook portion 114 can reboundback toward the inner lateral edge 116 c to retain the side port 16 orirrigation line 12.

Although not shown, any of the sheath adapter embodiments can includebarbs, threads, flanges, or other features to facilitate engagement withthe sheath 10, for example, a snap fit or a friction fit. These featurescan be used to engage the side port, irrigation line, or outer or innersurface of the procedural sheath hub. The addition of any of thesefeatures can also be used to permanently couple any of the sheathadapters described above and the sheath 10.

Terminology

As used herein, the relative terms “proximal” and “distal” shall bedefined from the perspective of the closure system. Thus, proximalrefers to the direction of the handle of the closure system and distalrefers to the direction of the distal tip of the closure system.

Conditional language used herein, such as, among others, “can,” “could,”“might,” “may,” “e.g.,” and the like, unless specifically statedotherwise, or otherwise understood within the context as used, isgenerally intended to convey that certain embodiments include, whileother embodiments do not include, certain features, elements and/orsteps. Thus, such conditional language is not generally intended toimply that features, elements, and/or steps are in any way required forone or more embodiments, whether these features, elements, and/or stepsare included or are to be performed in any particular embodiment.

The terms “comprising,” “including,” “having,” and the like aresynonymous and are used inclusively, in an open-ended fashion, and donot exclude additional elements, features, acts, operations, and soforth. Also, the term “or” is used in its inclusive sense (and not inits exclusive sense) so that when used, for example, to connect a listof elements, the term “or” means one, some, or all of the elements inthe list.

The terms “approximately,” “about,” and “substantially” as used hereinrepresent an amount close to the stated amount that still performs adesired function or achieves a desired result. For example, the terms“approximately,” “about,” and “substantially” may refer to an amountthat is within less than 10% of the stated amount, as the context mayindicate.

The ranges disclosed herein also encompass any and all overlap,sub-ranges, and combinations thereof. Language such as “up to,” “atleast,” “greater than,” “less than,” “between” and the like includes thenumber recited. Numbers preceded by a term such as “about” or“approximately” include the recited numbers. For example, “about 10percent” includes “10 percent.”

Any methods disclosed herein need not be performed in the order recited.The methods disclosed herein include certain actions taken by apractitioner; however, they can also include any third-party instructionof those actions, either expressly or by implication. For example,actions such as “tamping the sealant” include “instructing tamping ofthe sealant.”

Although certain embodiments and examples have been described herein, itwill be understood by those skilled in the art that many aspects of theclosure system shown and described in the present disclosure may bedifferently combined and/or modified to form still further embodimentsor acceptable examples. All such modifications and variations areintended to be included herein within the scope of this disclosure. Awide variety of designs and approaches are possible. No feature,structure, or step disclosed herein is essential or indispensable.

Some embodiments have been described in connection with the accompanyingdrawings. However, it should be understood that the figures are notdrawn to scale. Distances, angles, etc. are merely illustrative and donot necessarily bear an exact relationship to actual dimensions andlayout of the devices illustrated. Components can be added, removed,and/or rearranged. Further, the disclosure herein of any particularfeature, aspect, method, property, characteristic, quality, attribute,element, or the like in connection with various embodiments can be usedin all other embodiments set forth herein. Additionally, it will berecognized that any methods described herein may be practiced using anydevice suitable for performing the recited steps.

For purposes of this disclosure, certain aspects, advantages, and novelfeatures are described herein. It is to be understood that notnecessarily all such advantages may be achieved in accordance with anyparticular embodiment. Thus, for example, those skilled in the art willrecognize that the disclosure may be embodied or carried out in a mannerthat achieves one advantage or a group of advantages as taught hereinwithout necessarily achieving other advantages as may be taught orsuggested herein.

Moreover, while illustrative embodiments have been described herein, thescope of any and all embodiments having equivalent elements,modifications, omissions, combinations (e.g., of aspects across variousembodiments), adaptations and/or alterations as would be appreciated bythose in the art based on the present disclosure. The limitations in theclaims are to be interpreted broadly based on the language employed inthe claims and not limited to the examples described in the presentspecification or during the prosecution of the application, whichexamples are to be construed as non-exclusive. Further, the actions ofthe disclosed processes and methods may be modified in any manner,including by reordering actions and/or inserting additional actionsand/or deleting actions. It is intended, therefore, that thespecification and examples be considered as illustrative only, with atrue scope and spirit being indicated by the claims and their full scopeof equivalents.

1. A closure system for closing a puncture in a vessel wall, the closuresystem comprising: an inner catheter extending through the outercatheter and having an expandable structure at a distal end thereof; asealant positioned proximal to the expandable structure; a support tubeproximal to the sealant; and a handle portion at the proximal end of theinner catheter, the handle portion having a tension indicator configuredto indicate information associated with an amount of tension beingapplied to the vessel wall by the expandable structure.
 2. The closuresystem of claim 1, wherein the tension indicator comprises a visual cueto a user when proper tension is applied on the expandable structure. 3.The closure system of claim 2, wherein the visual cue is exposed withina tension indicator window on the handle portion.
 4. The closure systemof claim 1, wherein the tension indicator comprises a sliding pieceinside of the handle portion that moves distally based upon the tensionapplied on the expandable structure.
 5. The closure system of claim 1,wherein the tension indicator comprises a tension spring, wherein thetension indicator can move in a distal direction when a force on theexpandable structure exceeds a pre-load on the tension spring.
 6. Theclosure system of claim 1, wherein the handle portion further comprisesan actuator configured to both deploy the sealant within the arteriotomyand to tamp the sealant against a vessel wall of the arteriotomy, andwherein the handle portion further includes a lockout feature to preventthe actuator from being actuated unless a determined amount of tensionis being applied to the vessel wall by the expandable structure.
 7. Theclosure system of claim 1, wherein tension is adjustable via the handleportion.
 8. The closure system of claim 1, further comprising an outercatheter.
 9. The closure system of claim 1, further comprising a sheathadapter having an attachment structure, wherein the attachment structuredefines a passageway for releasable attachment to a procedural sheath bypositioning a side port or an irrigation line of the procedural sheathinto the passageway of the attachment structure.
 10. A closure systemfor closing a puncture in a vessel wall, the closure system comprising:an outer catheter; an inner catheter extending through the outercatheter and having an expandable structure at a distal end thereof; asealant positioned in a distal end of the outer catheter; a support tubeproximal to the sealant; and a handle portion at the proximal end of theinner catheter, the handle portion comprising an actuator configured toboth deploy the sealant within the arteriotomy and to tamp the sealantagainst a vessel wall of the arteriotomy.
 11. The closure system ofclaim 10, wherein the actuator is actuatable to move the outer catheterproximally and to move the support tube distally.
 12. The closure systemof claim 10, wherein the handle portion further includes a push rackconnected to the support tube.
 13. The closure system of claim 12,wherein the actuator includes a distal face configured to engage thepush rack to shift the push rack in the distal direction, thereby movingthe support tube in a distal direction to tamp the sealant.
 14. Theclosure system of claim 13, wherein full depression of the actuatorcauses exposure of the contact ramp on the push rack internal to thehandle portion.
 15. The closure system of claim 10, wherein the outercatheter extends distally from the handle portion, the outer cathetercomprising a proximal section and a distal section, wherein the distalsection of the outer catheter comprises an inner sleeve and an outersleeve surrounding the inner sleeve.
 16. The closure system of claim 10,wherein the handle portion further includes a pull rack including acontact ramp configured to engage with the actuator, the pull rack beingconnected to an outer sleeve of the outer catheter.
 17. The closuresystem of claim 16, wherein partial depression of the actuator causesthe pull rack to move in a proximal direction, which causes the outersleeve to move in a proximal direction to expose the sealant.
 18. Theclosure system of claim 10, further comprising a sheath adapter havingan attachment structure, wherein the attachment structure defines apassageway for releasable attachment to a procedural sheath bypositioning a side port or an irrigation line of the procedural sheathinto the passageway of the attachment structure.
 19. A closure systemfor closing a puncture in a vessel wall, the closure system comprising:an inner catheter having an expandable structure at a distal endthereof; a sealant positioned proximal to the expandable structure; asupport tube proximal to the sealant; a handle portion at the proximalend of the inner catheter, the handle portion having an actuatorconfigured to deflect a portion of the inner catheter and withdraw theexpandable structure proximally.
 20. The closure system of claim 19,wherein the handle portion further comprises a lockout mechanismconfigured to prevent the actuator from being actuated when theexpandable structure is in an expanded state.
 21. The closure system ofclaim 19, wherein the handle portion further comprises an inflationindicator at a proximal end thereof, wherein the inflation indicator isconfigured to move from a first position to a second position when theexpandable structure is fully expanded.
 22. The closure system of claim21, wherein in the second position the inflation indicator protrudesfrom a proximal end of the handle portion.
 23. The closure system ofclaim 21, wherein the inflation indicator provides a lockout mechanismconfigured to prevent the actuator from being actuated when theexpandable structure is in an expanded state.
 24. The closure system ofclaim 23, wherein the lockout feature comprises a plurality ofprotrusions on the inflation indicator, the plurality of protrusionsbeing configured to prevent the actuator from being depressed when theexpandable member is in an expanded state, and wherein the protrusionsshift distally when the expandable structure is deflated.
 25. Theclosure system of claim 19, wherein the actuator includes an armconfigured to engage with the inner catheter to bend the inner catheteraway from a central axis of the handle portion, thereby causing theexpandable structure to retract into the support tube.
 26. The closuresystem of claim 19, further comprising a sheath adapter having anattachment structure, wherein the attachment structure defines apassageway for releasable attachment to a procedural sheath bypositioning a side port or an irrigation line of the procedural sheathinto the passageway of the attachment structure.